ABPI bid to overturn NICE’s budget impact rules fails

One in five new medicines would have been affected by the rejected policy

The UK pharmaceutical trade body has failed in an attempt to force a judicial review of the new evaluation process introduced by the National Institute for Health and Care Excellence (NICE) earlier this year.

The Association of the British Pharmaceutical Industry (ABPI) has been fighting a legal action to try to overturn NICE’s introduction of a £20m cost ceiling for new drugs that have already been assessed as cost-effective, a measure that could allow it to delay introduction for up to three years.

The High Court rejected the ABPI’s application to have the changes to the evaluation process struck down, which the trade body claimed were “inappropriate and unworkable”, would limit patient access to new treatments and lay outside the cost-effectiveness organisation’s remit. It said around one in five new medicines would be affected by the policy.

In a statement, it said: “The ABPI is disappointed that the judicial review application has been turned down. It’s now appropriate for us to take time to reflect on the judgement with our members and decide next steps.”​

NHS England said in a statement that the High Court “has rejected ABPI’s flawed legal manoeuvres which the judge said would ‘produce an absurd result”.

“Rather than attempting to further frustrate NICE and the NHS’ work to ensure patients and taxpayers get maximum value out of the £15bn being spent on drugs, it now makes sense to work together towards that shared goal,” it continued.

In addition to the £20m budget cap, NICE also introduced a fast-track approval mechanism for treatments that offer ‘exceptional value for money’, and new rules on how it evaluates treatments for very rare conditions, raising the upper threshold limit to £300,000 from £100,000 for treatments considered to offer substantial clinical benefit.

Last year, the NHS spent £16.8bn on medicines, according to the British Medical Journal, up 8% on the prior year and almost £4bn more than was spent in 2011.